OHMEDA POSI-PULSE SUCTION UNIT— 510(k) K861261

Name: FDA 510(k) clearance K861261
Creator: U.S. Food and Drug Administration
Published: 1986-05-30

Substantially Equivalent

Ohmeda Medical

FDA 510(k) clearance K861261 for OHMEDA POSI-PULSE SUCTION UNIT, Substantially Equivalent on 1986-05-30. Applicant: Ohmeda Medical. Device class: 2.

Clearance details

Applicant: Ohmeda Medical
Product code: Code GCX
Device class: Class 2
Regulation: 21 CFR 880.6740
Advisory panel: General Hospital
Date received: 1986-04-04
Decision date: 1986-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

Download summary PDF View on FDA.gov ↗

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K042454 — STRYKER CASSETTE PUMP2004-12-09
K992126 — CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM1999-08-03
K972074 — SUCTION INSTRUMENTATION1997-07-25
K971022 — CHASE SUCKER1997-04-17
K964127 — MEDI-VAC FLEXI-CLEAR SUCTION HANDLE1996-12-31

More clearances from Ohmeda Medical

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K123309 — GIRAFFE AND PANDA WARMERS2013-02-05
K101778 — GIRAFFE INCUBATOR2010-07-21
K101788 — GIRAFFE OMNIBED2010-07-21
K090697 — MODIFICATION TO: GIRAFFE AND PANDA WARMER2009-04-16
K072157 — MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY)2007-08-27

Adverse events under product code GCX

product code GCX

Death: 9
Malfunction: 592
Other: 2
Total: 603

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.